1. Field of the Invention
The invention relates to a container for the mixing of media, in particular as a disposable container, which has at least one closable opening for the introduction and/or removal of the media and has a first sensor for measurement of at least one parameter of the mixture.
The subject invention also relates to a method for the mixing of media in a container, in particular a disposable container, in which at least one medium is introduced and mixed with at least one further medium, in which case parameters of the mixture can be measured by means of a sensor.
2. Description of the Related Art
In the pharmaceutical/biotechnological industry, sterile liquids have not only to be placed in different containers, transported and stored in widely differing applications, but also have to be manipulated. This includes, for example, mixing processes in which liquid or solid media must be added to the sterile liquids, and must be mixed with one another in a controlled manner. In addition, this also has to be done in sterile conditions.
Typical applications in this case are “virus deactivation” or the use of buffers. In the “virus deactivation” application the aim is to deactivate viruses which may be present in pharmaceutical/biotechnological sterile products (sterile liquids in the process scale >10 1) by means of a massive change in the pH value. For this purpose, a pH-changing solution or solid is added to the sterile product until a defined pH value is reached.
Sterile buffers are an important medium, for example for chromatography, as separation processes in the pharmaceutical/biotechnological industry. These buffers are produced by the addition of solids or liquid solutions to very pure sterile water, followed by a mixing process. In this case, one relevant criterion is also that the buffers be in sterile form, since processes are frequently chosen in which the buffers are produced from stock and therefore have to be stored for days or weeks.
Since the examples referred to for applications in the pharmaceutical/biotechnological industry relate to conventional validated processes, which require continuous checking of the state of the liquids and of the process steps, it is necessary to measure the process variables, such as the temperature or pH value of the sterile liquids.
It is known for steel or glass containers to be used which can be sterilized for the abovementioned processes, into which conventional measurement techniques (pH electrodes) or mixing techniques (stirrers) are introduced. This not only results in high investment costs (stainless steel containers, sterile technology, etc.) but also in high process costs as well as tedious processes (validated sterilizations by steam, etc.). The storage of sterile liquids in particular cannot be implemented using this technique, both as a result of sales aspects and because of the space required.
WO 2005/068059 A1 discloses a container for the mixing of media, which has at least one closable opening, for the introduction and/or removal of the media. Furthermore, the known mixing bag has a sensor for the measurement of a parameter of the mixing process, as well as a stirrer. The mixing bag can in this case be made available to the user in an already sterilized form.
This known mixing bag has the disadvantage of inadequate adaptation to measurement and control processes. In particular, flows with different turbulences occur in flexible mixing bags such as these—even when using a stirrer which is arranged in the bag—which leads to different degrees of mixing, at least at times. When a sensor is used, this can lead to incorrect measurements or, because of the different flows in different area elements, to undesirable exceeding of an intended value, at least at times.
One object of the present invention is thus to improve the known mixing containers such that monitored mixing can be carried out as far as possible without additionally exceeding the intended values or other predetermined values. A further aim is to achieve this at as low a cost as possible.